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Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc Recalls

All product recalls associated with Medtronic Sofamor Danek USA Inc.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 23041–23060 of 25000 recalls

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide

1...1151 115211531154 1155...1250

Page 1153 of 1250Next

• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, Satellite System Sphere PEEK, Si...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 8 mm Curette, size 8 mm, Materia...

Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material ...

Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Satellite Spinal System Surgical Technique, LITSATFUSST7-...

Surgical manual/technique lack information required as a condition of the 510(k) approval.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Philips Medical Systems: Philips PageWriter Touch Cardiograph, Model: 860284, Phil...

Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.

FDASep 12, 2007Nationwide• Philips Medical Systems

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch d...

Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

FDASep 10, 2007AL, AZ, FL +7 more• Terumo Cardiovascular Systems Corp

Gambro Renal Products, Inc.: Gambro cartridge blood tubing set used with Gambro Dasco ...

Kinked tubing on hemodialysis device may cause hemolysis.

FDASep 10, 2007Nationwide• Gambro Renal Products, Inc.

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Philips Medical Systems (Cleveland) Inc: Philips Medical Systems, Cardiac Viewer or Pulmonary View...

Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.

FDASep 10, 2007AL, AK, AZ +44 more• Philips Medical Systems (Cleveland) Inc

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-O...

Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.

FDASep 10, 2007Nationwide• Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Apex Destiny Security System Panels – Warning Failure (2007)

The recall involves Apex-Brand Destiny 6100 and 6100AN home security system control panels with XICOR-brand memory chips. Only units with a date code between K015 and K057 are subject to the recall. The date code appears on the product packaging. The date code includes a letter to designate the year (K=2007) followed by three numbers that indicate the day. For example, a product manufactured on the 5th day of January 2007 would have the date code "K005."

CPSCSep 6, 2007Nationwide• Ademco de Juarez SRL, of Mexico (control panel)